NCT07248345

Brief Summary

This study explores the effects of a virtual reality intervention on family caregivers of persons living with dementia

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

November 25, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Dementia

Keywords

family caregiverdementiavirtual reality

Outcome Measures

Primary Outcomes (6)

  • Caregiving Balance

    The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale

    1st month follwing VR intervention

  • Caregiving Balance

    The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale

    3rd month follwing VR intervention

  • Caregiving Balance

    The balance between competing needs will be assessed using the Caregiving Process of Finding a Balance Point scale

    6th month follwing VR intervention

  • Caregiver role strain

    Role strain will be measured by the 87-item Role Strain Scale from the Family Caregiving Inventory (FCI)

    1st month following VR intervention

  • Caregiver role strain

    Role strain will be measured by the 87-item Role Strain Scale from the Family Caregiving Inventory (FCI)

    3rd month following VR intervention

  • Caregiver role strain

    Role strain will be measured by the 87-item Role Strain Scale from the Family Caregiving Inventory (FCI)

    6th month following VR intervention

Secondary Outcomes (9)

  • Health Related Quality of Life

    1st month following VR intervention

  • Health Related Quality of Life

    3rd month following VR intervention

  • Health Related Quality of Life

    6th month following VR intervention

  • Depressive symptoms

    1st month following VR intervention

  • Depressive symptoms

    3rd month following VR intervention

  • +4 more secondary outcomes

Other Outcomes (3)

  • Caregiving demands

    1st month following VR intervention

  • Caregiving demands

    3rd month following VR intervention

  • Caregiving demands

    6th month following VR intervention

Study Arms (2)

virtual reality

EXPERIMENTAL

virtual interventions using VR scenarios related to competing demands for family caregivers of PLWD

Behavioral: virtual reality intervention

information

NO INTERVENTION

information regarding dementia will be provided

Interventions

virtual reality interventionBEHAVIORAL

virtual interventions using VR scenarios related to competing demands for family caregivers of PLWD

virtual reality

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- has the primary responsibility for providing direct care or supervising the care received by the PLWD, and is living with the PLWD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Yea-Ing Shyu

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yea-Ing Shyu, PhD

CONTACT

+886978697460yeaing@mail.cgu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

November 25, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share